BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3020106 · Received March 25, 2013

    Report

    Report Number
    1416980-2013-07173
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS NOT RETURNED, THEREFORE A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CUSTOMER REPORTED CONDITION COULD NOT BE CONFIRMED, NOR COULD A CAUSE BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM ERROR (SE) 2367 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) RECEIVED THE SE 2367 AND TSR HAD THE HP CHECK THE ALARM LOG. THE ORIGINAL ALARM WAS A SE 2240 (AIR IN LINE) ALARM, WHICH IS FOLLOWED BY A SE 2367. PROPER PROCEDURES, PER THE USER MANUAL, WERE REVIEWED WITH THE REPORTER, HOWEVER, NO REASON FOR THE SE 2240 COULD BE DETERMINED. THE HP WOULD COMPLETE THERAPY WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO PATIENT INJURY NOR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122168 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOME CHOICE